AccessGUDID - DEVICE: Water-Jel (00743537001095)

GUDID

Device Identifier (DI) Information

Brand Name: Water-Jel
Version or Model: CJ-BULK.77.000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CJ-BULK.77.000
Company Name: WATER-JEL TECHNOLOGIES, L.L.C.

Primary DI Number: 00743537001095
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1728
Labeler D-U-N-S® Number*: 155522589 *Terms of Use

Device Description: Cool Jel unit dose 1728 pcs/cs bulk, ASO 191317; Cool Jel

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47694	Burn gel	A substance intended to be applied directly to a minor burn or sunburn to protect against infection, minimize trauma and skin damage, moisten and cool the burn area, and prevent burn progression. It is typically available in sachets, bottles, or spray containers as a gel or spray and is used by emergency medical services (EMS) and critical care units, but may also be used in the home. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MGQ	Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K003396	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 028a92df-84f3-42dc-b3be-7e65edc92fa4
Public Version Date: November 11, 2024
Public Version Number: 1
DI Record Publish Date: November 01, 2024